Acetoin

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetoin

EC Number:

208-174-1

EC Name:

Acetoin

Cas Number:

513-86-0

Molecular formula:

C4H8O2

IUPAC Name:

3-hydroxybutan-2-one

Test material form:

liquid

Remarks:

a colourless liquid

Test animals / tissue source

Species:

cattle

Strain:

other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany

Details on test animals or tissues and environmental conditions:

The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour and 10 minutes.

Test system

Vehicle:

not specified

Amount / concentration applied:

750 µL

Duration of treatment / exposure:

10 minutes at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

2 hours at 32 ± 1 °C

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

ca. 121.82

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item Acetoininduced serious eye damage on the cornea of the bovine eye. The calculated mean IVIS was 121.82.

Any other information on results incl. tables

IVIS	UN GHS
≤ 3	No category
> 3 and≤ 55	No prediction can be made
> 55	Eye damage Category I

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of this study, the test item Acetoin induced serious eye damage on the cornea of the bovine eye. The calculated mean IVIS was 121.82.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 55 induces serious eye damage, that should be classified as UN GHS Category I.